A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir

HIV Infections Clinical Trial

Official title:

A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002452
• Other study ID #: 300A
• Secondary ID: 008-00
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2000
• Last updated: June 23, 2005

Study information

• Verified date: February 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).

Description:

All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are at least 18 years old.

• Have a viral load of at least 1,000 copies/ml.

• Have a CD4 cell count of at least 100 cells/mm3.

• Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.

Exclusion Criteria

You will not be eligible for this study if you:

• Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• L-756423

• Indinavir sulfate

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	The CORE Ctr	Chicago	Illinois
United States	Hawaii AIDS Clinical Trial Unit	Honolulu	Hawaii
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York
United States	Pittsburgh Treatment Ctr / Univ of Pittsburgh	Pittsburgh	Pennsylvania
United States	Georgetown Univ	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,